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Remote Quality Engineer Medical Device Jobs in California

Prismatik

Project Manager - Medical Device

Irvine, CA · On-site +1

$81K - $115K/yr

This is a hands-on role at the center of engineering, R&D, quality, and manufacturing, where you'll ... Remote or hybrid arrangements are not available. Employment Type: full-time

Primary.Health

QA Engineer (Remote)

CA · Remote

Remote JOB SCOPE: As a Quality Engineer at Primary you will be responsible for quality assurance related activities and following the complete end-to-end testing lifecycle including testing the ...

Stryker

Senior Staff Medical Writer (Remote)

San Diego, CA · On-site +1

$143K - $238K/yr

This position partners closely with Regulatory Affairs, Clinical Affairs, Quality, Research ... Expert knowledge of MEDDEV 2.7/1 Rev. 4, European Union Medical Device Regulation (EU MDR 2017/745 ...

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Remote Quality Engineer Medical Device information

What does a remote quality engineer in the medical device industry do?

A Remote Quality Engineer in the medical device industry is responsible for ensuring that medical products meet regulatory and quality standards while working from a remote location. Their duties often include reviewing and improving quality processes, conducting audits, analyzing data to identify trends or issues, and ensuring compliance with regulations such as FDA or ISO 13485. They collaborate with cross-functional teams to resolve quality issues and may also be involved in risk management and validation activities. Remote Quality Engineers use digital tools to communicate and manage documentation, making it possible to fulfill their role away from a traditional office or manufacturing environment.

How does a remote quality engineer in the medical device industry effectively collaborate with cross-functional teams despite working off-site?

Remote Quality Engineers in the medical device sector regularly use digital collaboration tools such as video conferencing, shared documentation platforms, and cloud-based quality management systems to stay connected with design, manufacturing, and regulatory teams. While working remotely poses challenges in terms of immediate access to physical devices and face-to-face communication, frequent virtual meetings and clear documentation help ensure alignment on project goals and compliance requirements. Building strong relationships with on-site team members and proactively seeking feedback are key strategies for maintaining effective collaboration and ensuring product quality.

What are the key skills and qualifications needed to thrive as a remote quality engineer in medical devices, and why are they important?

To thrive as a Remote Quality Engineer in Medical Devices, you need a solid background in quality assurance, regulatory compliance (such as FDA and ISO 13485), and engineering principles, typically supported by a relevant engineering degree. Proficiency with quality management systems (QMS), document control software, and risk assessment tools is common, and certifications like ASQ CQE are highly valued. Strong attention to detail, effective problem-solving, and clear remote communication skills help ensure compliance and collaboration across distributed teams. These abilities are crucial for maintaining product safety, meeting regulatory standards, and driving continuous improvement in a regulated industry.

What are the most commonly searched types of Quality Engineer Medical Device jobs in California?

The most popular types of Quality Engineer Medical Device jobs in California are:

What are popular job titles related to Remote Quality Engineer Medical Device jobs in California?

For Remote Quality Engineer Medical Device jobs in California, the most frequently searched job titles are:

What job categories do people searching Remote Quality Engineer Medical Device jobs in California look for?

The top searched job categories for Remote Quality Engineer Medical Device jobs in California are:

What cities in California are hiring for Remote Quality Engineer Medical Device jobs?

Cities in California with the most Remote Quality Engineer Medical Device job openings:

Remote Quality Engineer Medical Device jobs near you
Infographic showing various Remote Quality Engineer Medical Device job openings in California as of August 2026, with employment types broken down into 1% As Needed, 78% Full Time, 16% Part Time, and 5% Contract. Highlights an 92% Physical, 1% Hybrid, and 7% Remote job distribution.

Sr. Quality Assurance Engineer (ISO 13485)

Prismatik

Irvine, CA • On-site, Remote

$99K - $120K/yr

Full-time

Posted 21 days ago

Job description

We're looking for a Sr. QA Engineer to help build quality into every stage of our medical device development and manufacturing. You'll have broad ownership across quality engineering, risk management, CAPA, validation, and our Quality Management System. Working closely with cross-functional teams, you'll solve complex quality challenges, support new products and processes, and help ensure what we build meets the highest standards for safety, performance, and compliance.

Essential Functions:
  • Ensure compliance with applicable regulatory standards, including FDA 21 CFR Part 820, ISO 13485, MDSAP, and EU MDR.
  • Lead and support CAPA investigations, non-conformance management, and root cause analysis using tools such as 8D, Fishbone, and 5 Whys.
  • Own and continuously improve elements of the Quality Management System (QMS), including document control, internal audits, supplier quality, and change control.
  • Collaborate cross-functionally with R&D, Manufacturing, and Regulatory Affairs to support design control, risk management (ISO 14971), and product development lifecycle activities.
  • Lead internal and supplier audits, and support external audits and inspections (e.g., FDA, Notified Bodies).
  • Participate in validation activities (IQ/OQ/PQ) for processes, equipment, and software used in manufacturing and quality operations.
  • Develop, monitor, and analyze quality metrics to identify trends, drive continuous improvement, and ensure effectiveness of corrective actions.
  • Provide quality engineering support to Quality Control, including guidance on inspection methods, metrology, and measurement system capability.
  • Conduct and document investigations of NCRs, complaints, and deviations, providing effective and sustainable corrective and preventive actions based on engineering analysis.
  • Lead and mentor junior engineers, fostering technical growth and reinforcing a culture of quality and compliance.
  • Integrate ISO 14971 risk management and IEC 62366 usability engineering activities within Glidewell/Prismatik processes.
  • Ensure organizational compliance with the QMS through ongoing training, education, and internal communication.
  • Collaborate with Manufacturing and Engineering to coordinate pilot production, process validations, and risk analyses for new products and processes.
  • Ensure calibration and preventive maintenance systems meet compliance and operational requirements.
  • Identify and implement process optimizations using Lean and Six Sigma methodologies to improve manufacturability, reduce risk, and enhance efficiency.
  • Identify opportunities for design or re-design of equipment, tools, and fixtures to improve manufacturing processes and product quality.
  • Perform other related duties and special projects as assigned by management.
Minimum Qualifications:
  • Bachelor's degree in Engineering, Science, or a related technical field.
  • Minimum of 5 years of experience in Quality Assurance or Quality Engineering within the medical device industry, or equivalent education and experience demonstrating comparable skills and knowledge.
  • Strong working knowledge of FDA regulations, ISO 13485, and other applicable international quality standards.
  • Hands-on experience with risk management (ISO 14971), design controls, and validation methodologies.
  • Proven analytical, problem-solving, and communication skills.
  • Proficiency in quality and statistical analysis tools such as Minitab or equivalent software.
  • Demonstrated project management experience.
  • Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or Six Sigma certification, preferred.
  • Experience with combination products or Class I/II medical devices, preferred.
  • Familiarity with EU MDR and UDI regulatory requirements, preferred.
Pay range: $99,000 - $120,000/yr.
Exact compensation may vary based on skills and experience.
This role is fully onsite at our Irvine, CA campus. Remote or hybrid arrangements are not available.
Employment Type: full-time

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